Knowde Enhanced TDS
Identification & Functionality
- Carrier
- Chemical Family
- Polymer Name
- Technologies
- Product Families
Features & Benefits
- Labeling Claims
- Materials Features
- Specific Features
- Food-contact
- Reduced volatile content
Applications & Uses
- Markets
- Plastics & Elastomers End Uses
- Applications
Medical Equipment
- Application Details
- The following studies were performed on vulcanizates of SILPURAN® 6000/60 A/B according to ISO 10993:
- Cytotoxicity (ISO 10993-5)
- Sensitation LLNA (ISO 10993-10)
- Pyrogenicity (ISO 10993-11)
- The following studies were performed on vulcanizates of SILPURAN® 6000/60 A/B according to USP class VI:
- Acute systemic toxicity
- Intracutaneous toxicity
- Implantation test
- No adverse effects have been detected at any of the studies performed.
- Properly cured and post-cured vulcanizates of SILPURAN® 6000/40 A/B can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA 21 CFR §177.2600 "Rubber Articles Intended for Repeated Use" considering any given limitations on extractable and volatile substances.
Processing
The A and B components are delivered ready to use in 20 kg pail kits. With adequate metering equipment, they can be pumped directly from the original containers into the injection molding machine and mixed by a static mixer. The mixing ratio is 1 : 1. At room temperature, mixtures of A and B components have a pot life of at least three days.
- The following studies were performed on vulcanizates of SILPURAN® 6000/60 A/B according to ISO 10993:
Properties
- Physical Form
- Cured Properties
- Uncured Properties
- Properties
SILPURAN® 6000/60 A/B meets selected test requirements of ISO 10993 and United States Pharmacopeia (USP) Class VI. It is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days and is particularly suitable for the economical production of large series of injection molded articles.
At service temperatures above approx. 180 °C the addition of heat stabilizers is recommended. Further information about an improvement of the heat stability by use of specific ELASTOSIL® Color Pastes FL can be obtained from the Technical Information Sheet "ELASTOSIL® Color Pastes FL" or the latest edition of our brochures.- Note
Cure conditions: 5 min / 165 °C in press, post-cured 4 h / 200 °C
| Value | Units | Test Method / Conditions | |
| Compression Set (at 22 hours, 175°C) | 14 | % | DIN ISO 815-1 type B method A |
| Density | 1.13 | g/cm³ | DIN EN ISO 1183-1 A |
| Elongation (at break) | 350 | % | ISO 37 Type 1 |
| Shore Hardness A | 60 | — | DIN ISO 48-4 |
| Tear Strength | 27 | N/mm | ASTM D 624 B |
| Tensile Strength | 10 | N/mm² | ISO 37 Type 1 |
| Value | Units | Test Method / Conditions | |
| Dynamic Viscosity (Shear rate 1 s⁻¹) | 1080000 | mPa·s | DIN EN ISO 3219 |
| Dynamic Viscosity (Shear rate 10 s⁻¹) | 411000 | mPa·s | DIN EN ISO 3219 |
Regulatory & Compliance
- Certifications & Compliance
Packaging & Availability
- Country Availability
- Packaging Type
- Regional Availability
- Packaging Information
- This product is available in 20 kg pail kits. The packaging of SILPURAN® 6000/60 A/B is performed in accordance with class 8 clean room standards (DIN EN ISO 14644).
- SILPURAN® is neither produced nor packed under sterile conditions, so the final product has to be sterilized prior to use, if necessary
Storage & Handling
- Storage Information
Once opened, containers should always be resealed after use to prevent the platinum catalyst from being poisoned by amines, sulfur or phosphorus compounds.